DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of copending Application No. 18/025,128. Regarding claim 1 of the instant application, claim 1 of the copending application discloses a syringe with needle protection (claim 1, syringe; claim 4, passive needle protection), designed in the manner of a retraction system (claim 4, retraction of the hollow needle), the syringe comprising: a syringe housing (claim 1, syringe housing); a syringe needle (claim 1, hollow needle) that retracts into the syringe housing after the active substance held in the syringe housing has been dispensed (claim 4, retraction of the hollow needle); and a plunger which can be displaced in an interior of a syringe body of the syringe by means of an actuating plunger in the interior of the of a syringe body (claim 1, displaceable piston), which plunger has a needle holder provided for receiving the syringe needle (claim 1, needle holder) during retraction, wherein: the needle holder includes a retaining bracket which is integrally formed on a base body and which carries the actual needle bearing (claim 1, holding bracket which carries a needle bearing) forming a receiving hole for the needle (claim 1, forming a receiving hole for the needle), and the needle holder is in a piston jacket of a piston of the syringe (claim 1, piston jacket), which is shaped in such a way that, when the needle holder is inserted, the piston jacket leaves free inflow surfaces for the active substance on both sides of the holding bracket in such a way that a free space is created inside the piston, which, in the final phase of the application of the active substance, in which the needle tip of the needle has already penetrated into the receiving hole and is thus no longer readily accessible to the active substance, allows the active substance to flow into the needle tube via the needle tip in the manner of a bypass (claim 1, leaves free on both sides of the holding bracket inflow channels into the enclosed end of the hollow needle).
This is a provisional nonstatutory double patenting rejection.
Claim Objections
Claim 1 is objected to because of the following informalities: claim 1 recites “the active substance” in line 4. This limitation lacks antecedent basis. Claim 1 further recites “the needle tube” and “the needle tip” in the last clause. These limitations lack antecedent basis. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 5, 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cheng et al (US 2018/0280628).
Regarding claim 1, Cheng discloses a syringe with needle protection in the manner of a retraction system (abstract), the syringe comprising a syringe housing 110 (fig. 1A), a syringe needle 126 that retracts into the syringe housing after the active substance held in the syringe housing has been dispensed (page 1, para. 0004), and a plunger 130 which can be displaced in an interior of the body of the syringe by means of an actuating plunger 130 in the interior of the syringe body (fig. 1B), which has a needle holder 132 (fig. 2A)for receiving the syringe needle during retraction (fig. 2C), wherein the needle holder includes a retaining bracket 134 which is integrally formed on a base body 132 and which carries the actual needle bearing 1344 forming a receiving hole for the needle (fig. 2A), and the needle holder is arranged in a piston jacket 140 of a piston of the syringe (fig. 2A), which is shaped in such a way, that when the needle holder is inserted, the piston jacket leaves free inflow channels for the active substance on both sides of the holding bracket in such a way that a free space is created inside the piston, in which, in the final phase of the application of the active substance, in which the needle tip of the needle has already penetrated into the receiving hold and is thus no longer readily accessible to the active substance, allows the active substance to flow into the needle via the needle tip in the manner of a bypass (fig. 2A: open flow spaces on either side and between arms 1341; fig. 2B).
Regarding claim 2, Cheng discloses that the needle holder is manufactured as a plastic part (page 5, para. 0035: plunger assembly is plastic, plunger assembly includes needle holder).
Regarding claim 5, Cheng discloses that the syringe body is manufactured as a plastic part (page 5, para. 0035).
Regarding claim 7, Cheng discloses that the syringe body is manufactured as a plastic part (page 5, para. 0035).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 4, 6, 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheng in view of Luo et al (US 2008/0275394).
Claim 4 differs from Cheng in calling for the plunger jacket to be formed from rubber. Luo teaches a syringe having a plunger jacket formed from rubber (page 1, para. 0016). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plunger jacket of Cheng for be formed of rubber as taught by Luo to provide an elastic material that readily seals against the barrel wall to prevent leakage of the medicine.
Claim 6 differs from Cheng in calling for the plunger jacket to be formed from rubber. Luo teaches a syringe having a plunger jacket formed from rubber (page 1, para. 0016). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plunger jacket of Cheng for be formed of rubber as taught by Luo to provide an elastic material that readily seals against the barrel wall to prevent leakage of the medicine.
Regarding claim 9, Cheng discloses that the syringe body is manufactured as a plastic part (page 5, para. 0035).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheng in view of Kubo et al (US 2008/0255521).
Claim 8 differs from Cheng in calling for the syringe body to be formed from cyclo-olefin polymer (COP). Kubo teaches a syringe having a syringe body formed from cyclo-olefin polymer (COP) which is heat resistant to allow sterilization and non-staining (page 3, para. 0041). It would have been obvious to one or ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe body of Cheng to be formed from cyclo-olefin polymer (COP) as taught by Kobo to provide a heat resistant and non-staining material.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheng in view of Luo as applied to claim 9 above, and further in view of Kubo.
Claim 10 differs from Cheng in calling for the syringe body to be formed from cyclo-olefin polymer (COP). Kubo teaches a syringe having a syringe body formed from cyclo-olefin polymer (COP) which is heat resistant to allow sterilization and non-staining (page 3, para. 0041). It would have been obvious to one or ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe body of Cheng to be formed from cyclo-olefin polymer (COP) as taught by Kobo to provide a heat resistant and non-staining material.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheng in view of Castanon et al (US 10,765,815).
Claim 11 differs from Cheng in calling for the needle holder to be formed from polypropylene. Castanon teaches a syringe having a needle holder 90 (fig. 10) wherein the needle holder is formed from polypropylene which is a rigid material suitable for securely holding the needle (col. 10, lines 30-33). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle holder of Cheng to be formed from polypropylene as taught by Castanon to provide a material that is rigid enough to securely hold the needle.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783